Events

Recall of Device Recall Biomet Exact Calcar Planer Rasp Style Blade

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49013
  • Event Risk Class
    Class 2
  • Event Number
    Z-2370-2008
  • Event Initiated Date
    2008-07-18
  • Event Date Posted
    2008-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72516
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Blade - Product Code GFA
  • Reason
    The blades will oxidize after the first cleaning.
  • Action
    Distributors were notified via letter dated 7/18/08 to locate and remove the products and to return them. Distributors were instructed to conduct the recall to the hospital level and to notify the hospitals of the recall by copy of an undated recall letter. Contact Biomet, Inc. at 1-800-348-9500, ext. 3983 for assistance.

Device

Device Recall Biomet Exact Calcar Planer Rasp Style Blade
  • Model / Serial
    Lots 739370, 442250, 848550 and 904090.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and China.
  • Product Description
    Exact Calcar Planer Rasp Style Blade, 38mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473795. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46581-0587
  • Source
    USFDA